The exercise to weed out irrational and harmful drug combinations from the Indian pharmaceutical market was started by Drug Controller General of India in 2007. The action was initiated in the context of uncontrolled growth of fixed dose combination products with no therapeutic rationale and safety profile for several years. A majority of these FDCs available in the market are approved by State Drug Licensing Authorities and not by DCGI. FDCs are considered to be new drugs under Rule 122 (E) (c) of the Drugs & Cosmetics Rules and all new drugs have to be approved by DCGI for marketing in the country after submission of all relevant pre-clinical and clinical trial data. The DCGI Dr Venkateshwarlu had then prepared a list of 294 irrational FDCs and had directed the state drug authorities to withdraw licences issued for these combinations. But, the whole initiative got held up when the manufacturers moved Madras High Court challenging the DCGI order. The matter is still undecided and is still in the court. The SLAs have, however, stopped issuing product licences for new FDCs and such applications are being directed to the office of DCGI. But, the problem remains and thousands of irrational and harmful combinations are still being sold in the market place.
The Union health ministry, in the meanwhile, has started preparing another long list of irrational FDCs to be withdrawn from the market. It has already prepared a list of around 200 irrational FDCs and it is expected to be sent to the state drug licensing authorities directing them to withdraw licences issued to these combinations. These 200 include a number of combinations of atorvastatin, rabeprazole, and paracetamol with other drugs besides some multivitamin combinations. In fact, the domestic market is dominated by more of combinations than single ingredient drugs and the doctors also prefer to prescribe combinations drugs without considering their side effects on patients. It is understandable that for certain deadly diseases like MDR TB and diabetes, combination drugs may be inevitable as such patients have to take three to four drugs at a time. Now the health ministry's action comes in the backdrop of the recent report of the Parliamentary Standing Committee on Health. The panel was highly critical on the functioning of the CDSCO and called for a clear and transparent policy in approving FDCs based on scientific principles. The Committee felt that FDCs which are unauthorized and without the clearance of DCGI office can pose major risk to patients and needs to be withdrawn from the market without any delay. The Parliamentary panel’s comment in this regard should motivate the office of DCGI to act fast on the health ministry’s new list of irrational combinations.